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[汗液试验的分析质量及检测方法比较]

[Analytical quality of assays and comparison of procedures for the sweat test].

作者信息

Nguyen-Khoa Thao, Borgard Jean-Pierre, Marchand Martine, Sitruk-Khalfon Dominique, Feuillet Marie-Noëlle, Feldmann Delphine, Vassault Anne, Rota Michèle

机构信息

Laboratoire de biochimie A, CHU Necker Enfants Malades, AP-HP Paris.

出版信息

Ann Biol Clin (Paris). 2012 Jan-Feb;70(1):5-12. doi: 10.1684/abc.2011.0650.

DOI:10.1684/abc.2011.0650
PMID:22294136
Abstract

Sweat test measuring the chloride ion (Cl(-)) concentration in sweat is a tool for the cystic fibrosis (CF) diagnosis. We evaluated analytical criteria of different available methods and compared them into five hospitals and throught a national quality control program. Sweat tests were performed by stimulation using pilocarpine iontophoresis, sweat collection and measurement of sweat Cl(-) (mmol/L) by titration (colorimetric or coulometric end-point) or by in situ direct potentiometry using a chloride-selective electrode. Indirect determination by sweat conductivity measurement was expressed in mmol/L sodium chloride (NaCl) equivalents (Eq). Linearity range was demonstrated for all measurement procedures in the range 10 to 120 mmol/L. Intra-laboratory coefficients of variation (CVs) were <5% for values between 10 and 100 mmol/L. Inter-laboratory CVs were <3% only for conductivity measurement whatever the range. The comparison of results obtained for a same sweat sample, simultaneously by coulometric and conductivity measurements, demonstrated a first degree linear distribution between 30 to 60 mmol/L Cl(-) allowing us to establish an analytical correspondence table for this range. Thus, calculated values for 30, 40 and 60 mmol/L Cl(-) were respectively 57, 66 and 84 mmol/L NaCl Eq. In conclusion, comparison of methods highlighted that the less the sweat test is automatically controlled, the more the operator influence on results quality is important. Our study supports that sweat test result <50 mmol/L NaCl Eq is unlikely with CF diagnosis in absence of clinical arguments.

摘要

汗液测试通过测量汗液中的氯离子(Cl(-))浓度,是诊断囊性纤维化(CF)的一种手段。我们评估了不同现有方法的分析标准,并在五家医院以及通过一项全国质量控制计划对它们进行了比较。汗液测试通过毛果芸香碱离子电渗疗法进行刺激,收集汗液,并通过滴定法(比色或库仑终点法)或使用氯离子选择性电极进行原位直接电位测定法来测量汗液中的Cl(-)(mmol/L)。通过测量汗液电导率进行的间接测定以氯化钠(NaCl)当量(Eq)的mmol/L表示。所有测量程序在10至120 mmol/L范围内均显示出线性范围。对于10至100 mmol/L之间的值,实验室内变异系数(CVs)<5%。无论范围如何,仅电导率测量的实验室间CVs<3%。通过库仑法和电导率测量同时对同一汗液样本获得的结果进行比较,发现在30至60 mmol/L Cl(-)之间呈一级线性分布,这使我们能够为此范围建立一个分析对应表。因此,30、40和60 mmol/L Cl(-)的计算值分别为57、66和84 mmol/L NaCl Eq。总之,方法比较突出表明,汗液测试的自动化控制程度越低,操作员对结果质量的影响就越重要。我们的研究支持,在没有临床依据的情况下,汗液测试结果<50 mmol/L NaCl Eq不太可能用于CF诊断。

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[Analytical quality of assays and comparison of procedures for the sweat test].[汗液试验的分析质量及检测方法比较]
Ann Biol Clin (Paris). 2012 Jan-Feb;70(1):5-12. doi: 10.1684/abc.2011.0650.
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Sweat chloride quantification using capillary electrophoresis.使用毛细管电泳法定量汗液氯化物。
Pract Lab Med. 2018 Dec 7;13:e00114. doi: 10.1016/j.plabm.2018.e00114. eCollection 2019 Jan.
2
Performance Evaluation of a New Coulometric Endpoint Method in Sweat Testing and Its Comparison With Classic Gibson&Cooke and Chloridometer Methods in Cystic Fibrosis.一种新型库仑滴定终点法在汗液检测中的性能评估及其与囊性纤维化经典吉布森和库克法及氯度计法的比较
Front Pediatr. 2018 May 22;6:133. doi: 10.3389/fped.2018.00133. eCollection 2018.
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Optimization of the French cystic fibrosis newborn screening programme by a centralized tracking process.
通过集中跟踪流程优化法国囊性纤维化新生儿筛查项目。
J Med Screen. 2018 Mar;25(1):6-12. doi: 10.1177/0969141317692611. Epub 2017 Apr 28.